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Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease

This study is currently recruiting participants.
Verified March 2012 by Wenzhou Medical College
Sponsor:
Information provided by:
Wenzhou Medical College
ClinicalTrials.gov Identifier:
NCT01562795
First received: March 22, 2012
Last updated: March 23, 2012
Last verified: March 2012
History of Changes
  Purpose

This clinical trial is to investigate whether nonsteroid anti-inflammatory drops have therapeutic effect on moderate to severe dry eye patients.And compare the efficacy of the two nonsteroid anti-inflammatory drops with topical corticosteroids.


Condition Intervention
Moderate to Severe Dry Eye Disease
 Drug: nonsteroid anti-inflammatory drops plus artificial tear substitute
Drug: corticosteroids plus artificial tear substitute
Drug: artificial tear substitute

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wenzhou Medical College:

Primary Outcome Measures:
  • tear osmolarity [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • corneal staining [ Time Frame: 0 day,7th day and 14th day after treatment ] [ Designated as safety issue: Yes ]
  • Schirmer test(without anaesthesia) [ Time Frame: 0 day,7th day,14th day after treatment ] [ Designated as safety issue: No ]
  • tear film breakup time(TBUT) [ Time Frame: 0 day,7th day and 14th day after treatment ] [ Designated as safety issue: No ]
  • meibomian gland function [ Time Frame: 0 day,7th day and 14th day after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: March 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 1 Drug: nonsteroid anti-inflammatory drops plus artificial tear substitute
Other Name: prunoprefen
Experimental: group 2 Drug: nonsteroid anti-inflammatory drops plus artificial tear substitute
Other Name: bronuck
Experimental: group 3 Drug: corticosteroids plus artificial tear substitute
Other Name: Fluorometholone
group 4 Drug: artificial tear substitute

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • moderate to severe dry eye syndrome
  • tear film breakup time ＞0 second and ≤5 seconds,or schirmer test(no anaesthesia)≥2mm/5min and ≤5mm/5min
  • corneal staining≥3 scores

Exclusion Criteria:

  • allergic to any composition of the drugs under experiment
  • previous use of anti-inflammatory drugs or immunosuppressive agent
  • viral,bacterial or fungal infection of the eye
  • eyelid anomaly
  • glaucoma or high IOP
  • significant meibomian gland dysfunction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562795

Contacts
Contact: Wei Chen, MD，PhD 8613757728118 chenweimd@hotmail.com

Locations
China, Wenzhou/Zhejiang
Eye Hospital, Wenzhou Medical College Recruiting
Wenzhou,Zhejiang,China, Wenzhou/Zhejiang, China
Contact: Jinyang Li, MD     8613957713091     pinbol@163.com    
Sponsors and Collaborators
Wenzhou Medical College
Investigators
Principal Investigator: Wei Chen, MD,PhD Eye Hospital, Wenzhou Medical College, China
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01562795     History of Changes
Other Study ID Numbers: Xzhou
Study First Received: March 22, 2012
Last Updated: March 23, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Anti-Inflammatory Agents
Fluorometholone
Anti-Inflammatory Agents, Non-Steroidal
 Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 19, 2013